10 SALARIES AND EXPENSES For necessary expenses not otherwise provided for, of the Food and Drug Administration, including reporting and illustrating the results of investigations; purchase of chemicals, apparatus, and scientific equipment; payment in advance for special tests and analyses and adverse reaction reporting by contract; payment of fees, travel, and per diem in connection with studies of new developments pertinent to food and drug enforcement operations; compensation of informers; payment for publication of technical and informational materials in professional and trade journals; and rental of special purpose space in the District of Columbia or elsewhere; [$39,200,000] $50,352,000. (Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301-392); the Tea Importation Act, as amended (21 U.S.C. 41-50); the Import Milk Act (21 U.S.C. 141-149); the Federal Caustic Poison Act (15 U.S.C. 401-411); the Filled Milk Act, as amended (21 U.S.C. 61-64); and the Federal Hazardous Substances Labeling Act (15 U.S.C. 401); Departments of Labor, Health, Education, and Welfare Appropriation Act, 1965.) Program and Financing (in thousands of dollars) Identification code 09-05-0900-0-1-651 FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE General and special funds: 43 Program by activities: 1. Medical evaluation.... 2. Research. 46 3. Scientific evaluation.. 4. Education and voluntary compliance............ 5. Regulatory compliance....... 6. Executive direction and technical sup- Total program costs, funded. Financing: 11 Receipts and reimbursements from admin Change in selected resources 1. Total obligations.. istrative accounts. 25 Unobligated balance lapsing.. New obligational authority. New obligational authority: 40 Appropriation. 41 Transferred to "Operating expenses, Public Buildings Service" General Services Administration (77 Stat. 436 and 78 Stat. 655).. Appropriation (adjusted). Proposed transfer from "Assistance to Relation of obligations to expenditures: 10 Total obligations..... 70 Receipts and other offsets (items 11-17).. 71 Obligations affecting expenditures.... 1964 actual 3.193 4,771 2,036 1,117 20,016 3,192 34,325 35,038 -60 35,621 35,805 -184 35,621 35,038 -60 34,978 Program and Financing (in thousands of dollars)—Continued 50.443 50,352 3. Scientific evaluation.-Scientific evaluations are made of pesticide, food additive, color additive, and food standards petitions, and the labeling of hazardous substances. Regulations are developed and promulgated for pesticide tolerances and exemptions, food additives, color additives, food standards, antibiotic, and insulin. Antibiotics, insulin, and certain colors are certified. Toxi50,352 cological evaluations are performed concerning investigational drugs and new drug applications. Methods and bases for evaluation of petitions and tolerances are developed and studied. 4. Education and voluntary compliance. -This activity encompasses the planning, conduct, and evaluation of programs to obtain voluntary compliance with laws on the part of the regulated industries and to inform con 2. Research.-Broad and long-range research is conducted concerning foods, drugs, and cosmetics and related products. The research includes fundamental research concerning the effects and interrelationships of substances occurring in the products that FDA regulates and experimentation to find new and better methods of detecting and identifying harmful and insanitary substances to add to the cumulative knowledge concerning man and the products he consumes. FOOD AND DRUG ADMINISTRATION-Continued SALARIES AND EXPENSES-Continued Number of establishments inspected..... sumers of the objectives of the laws and to help prepare tic import..---- Informational and guidance materials are prepared and distributed to assist industry in voluntary compliance and to promote understanding of FDA regulations and policies. Working relationships are established and maintained with industry, trade, and professional organizations. Studies, surveys, and evaluations are made of consumer attitudes, interests, prejudices, purchasing, and other trends. Printed and graphic materials are prepared and published on subjects of consumer interests for dissemination to the general public and news media. Consumer consultants are used to provide consultation services, furnish information and materials, and make speeches and presentations to consumer and other groups. 5. Regulatory compliance.-Nationwide inspectional, investigational, and analytical programs are conducted to enforce the Food, Drug, and Cosmetic Act, Hazardous Substances Labeling Act, and related statutes. Central direction and coordination of the inspectional and analytical programs and operations performed in the 18 district offices insures consistency in the enforcement of the laws. Inspectional, investigational, and other field actions are reviewed to evaluate the degree of compliance or noncompliance with the provisions of the law; from these reviews determinations are made for securing compliance through legal or voluntary action. Initiates and directs the preparation of legal cases for enforcement of the law and those designed to test and interpret the law. Workload is reflected in the following summary data: 1964 actual 1965 estimate 1966 estimate 37,800 36,000 36,000 41,978 40,000 40,000 6. Executive direction and technical support.—This activity includes the establishment of goals and policy; the formulation and promulgation of agencywide plans, regulations, and directives; the allocation of resources; the day-to-day direction of the agency; and the evaluation of performance and accomplishments. Programs are conducted to promote cooperative Federal-State relations; to disseminate information to the press and general public, to prepare for operations under emergency conditions, and to obtain the services of outside consultants. Technical support is provided on an agencywide basis in the areas of financial management, facilities planning, laboratory cleaning and needed preparation services, technical reference services, procurement and property, records, data processing, management services, personnel, and training. Identification code 11.1 11.3 11.4 11.5 101,000 15,451 13,607 108,541 Personnel compensation: 1964 actual Personnel Summary 15.427 13,607 112,752 104,000 107.000 1965 1966 estimate estimate 3,818 27 3,413 8.2 $7,653 $5,492 15,500 14,000 113,000 136 31 120 25,491 30,166 33.663 1.891 2,312 2.466 1,375 1,568 2,176 591 616 258 286 910 424 1,060 600 1,415 471 656 40,431 1,710 568 3,565 695 2,410 500 1,788 50,443 4,046 4,448 27 31 3,720 4.043 8.3 8.4 $8,181 $8.289 $5.628 $5.513 BUILDINGS AND FACILITIES For construction, alteration, and [equipment,] equipment of facilities, including acquisition of sites, and planning, architectural, and engineering services, [$10,875,000 $6,324,000, to remain available until expended. (Departments of Labor, and Health, Education, and Welfare Appropriation Act, 1965.) Note.-Estimate is for activities previously carried under Pharmacological animal laboratory building and Salaries and expenses. Parts of the amounts obligated in 1964 and 1965 are shown in the schedule as comparative transfers. Since 1958, the Food and Drug Administration in collaboration with the General Services Administration has been engaged in a program to improve and enlarge its field facilities, and funds have been appropriated for all phases of modernization for 13 of the 18 FDA district offices. 1964 actual 313 -432 1,014 895 -426 469 -89 4,087 4,466 469 -89 379 -66 313 25.2 1965 1966 estimate estimate 99.0 245 65 2,028 60 2,398 12,617 15,015 -53 -4,087 10,875 15,015 -53 14,962 66 -12,629 2,399 5,469 9,585 782 Identification code 15,851 -9,527 6,324 6,324 6,324 6,324 12,629 -11,614 7,339 Analysis of 1966 financing 1 Selected resources as of June 30 are as follows: Unpaid undelivered orders. 1963, $1.279 thousand (1964 Deduct selected resources and unobligated balance, start of year 3,740 15 8,935 FOOD AND DRUG ADMINISTRATION 25.2 Services of other agencies. In addition to improvements in its field facilities, FDA The program proposed for 1966 calls for: (1) Acquisition of portable laboratory equipment for Federal office building No. 8 and the modification of office space to accommodate additional scientific personnel in 1966. (2) Planning for an additional headquarters laboratory Services of other agencies. ALLOCATION TO GENERAL SERVICES Add resources Object Classification (in thousands of dollars) 1964 actual Total obligations, Food and Drug Ad- 3,945 facility at the Beltsville site to house approximately 450 personnel. (3) Construction of district office facilities at St. Louis and San Francisco, and the equipping of district office facilities authorized for construction at Chicago, Denver, and Philadelphia. Total obligations, General Services Total obligations............... 13,472 3,945 6,324 11,910 65 65 Appropriation reAppropri- quired to ation complete required, 1966 113 291 1,729 404 469 4,595 11,512 761 664 398 1,425 1965 1966 estimate estimate 375 1,400 705 2,480 863 604 12,727 3,240 13,590 3,844 15,015 6,324 1964 actual Public enterprise funds: REVOLVING FUND FOR CERTIFICATION AND OTHER SERVICES 17 Increase in customers' advances.. Recovery of prior year obligations.. 21.98 Unobligated balance, start of year. 22.98 Unobligated balance transferred from "Salaries and expenses, certification, inspection, and other services" (77 Stat. 229). 24.98 Unobligated balance available end of year.... New obligational authority. 89 -142 53 89 89 1,001 -22 1,069 1964 actual 1,574 43 58 143 2,238 -109 2,273 -21 -2,233 -33 -17 1965 estimate -1.189 1.220 53 -53 333 53 33243 53 22 75 1,768 392 45 51 1965 1966 estimate estimate 2,256 473 2,729 2,729 -25 -2,312 1966 estimate -1,220 828 2,276 263 2,539 2,539 -25 -2,433 -828 747 In 1964, this account was converted from an indefinite special fund to a self-sustaining revolving fund. The workload in pesticide tolerances decreased sharply in 1964 as a result of the establishment of a new requirement for certification that caused most manufacturers to withhold their petitions until certain time-consuming reproduction studies were completed and their results could be included with the petitions. This means that activity in this area will return to normal in 1965; i.e., to a 45 level comparable to that maintained in 1963. Workload data are as follows: 1.758 392 81 Net loss, antibiotics....... 1964 actual Color additives: Revenue... 2,273 -2,304 -31 Net gain, color additives.......... 287 -367 -||| Insulin: Revenue... Expense. 2,160 -2,271 1 Balances of selected resources are identified on the statement of financial condition. Net gain or loss, insulin............... The Food and Drug Administration certifies batches of antibiotics, insulin, and color additives for use in food, drugs, or cosmetics; it also establishes tolerances for residues of pesticide chemicals in or on raw agricultural products and for color additives in foods, drugs, and cosmetics. These services are financed wholly by fees paid by the industries affected. 37 40 182 31 200 Revenue, Expense, and Retained Earnings (in thousands of dollars) 1964 actual 1.588 1,589 -1 581 436 145 1965 estimate 2.729 -2,337 392 49 367 -380 379 1963 1964 1965 1966 actual actual estimate estimate 17,708 22,700 24,000 24,000 350 350 6,800 6,800 398 5,812 378 6,302 6 6 2,716 2,535 -2,337 -2,458 1966 estimate 2,539 -2,458 81 1965 estimate 380 -38 -77 1.785 1.859 -74 450 416 34 49 52 -3 40 200 1966 estimate 1,870 1,849 21 450 422 28 50 52 -2 1965 1966 estimate estimate 266 2 214 8.3 $8,181 8 8 8.2 $7,653 141 1 142 142 1965 1966 estimate estimate -138 -4 142 -142 1 Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1963, $21 thousand; 1964, $23 thousand; 1965, $23 thousand; 1966, $23 thousand. Object Classification (in thousands of dollars) 1964 actual 266 2 36 142 228 8.4 $8.289 20 9 8.3 $8,181 145 1 146 146 1965 1966 estimate estimate -142 146 -146 97 7 6 36 146 20 9 8.4 $8,289 |